The present invention relates to a system and methods for generating unique films for packaging of medical supplies. The films disclosed herein must be able to be autoclaved in order to sterilize the medical supplies. Additionally, the films, when manufactured into a packaging must be durable enough to protect the contents and have a low permeability to moisture.
Packages made from polymer films are known in the medical device and supply industry. These film packages are traditionally thermo sealed pouches containing the medical supply. The entire packaged medical supply is then subjected to autoclaving in order to sterilize the supplies. In some cases, the medical supplies may be irradiated within the packaging or, alternatively, chemically sterilized.
Traditionally, polyethylene or polypropylene are common substances utilized as films for medical device packaging. The typical film material used in medical supply packaging is a single layer of High Density Polyethylene (HDPE). These films are durable, and when manufactured to a proper thickness, provide the needed moisture barrier required for packaging moisture dependent medical supplies. For example, Intravenous (IV) bags containing saline or glucose solutions require a very low moisture transmission rate out of the packaging material because solution concentration and final volume are reliant upon not loosing moisture over time. However, thick HDPE films has drawbacks in terms of workability and cost due to film thickness. As such, alternate films have been developed.
A class of such films includes co-extrusion of differing densities of polyethylene materials in a single film, a procedure pioneered by the inventors of this disclosure. These films typically include two or more layers of polyethylene, each layer has a different density mixture designed to impart moisture resistance and strength. Additionally, by making the heat resistant layer having a higher melting temperature than the heat seal layer, it is possible to have greater tolerance during manufacturing. Additionally, this enables the sealing temperature to be lower than the melting temperature of the heat resistant layer of the film. By increasing manufacturing tolerances, it is possible to reduce packaging failures, which is particularly costly in the medical supply industry.
While past improvements made in films have improved failure rates in medical supply packaging, there remains room for further improvements. Additionally, there is a constant pressure to reduce material cost while still increasing performance.
It is therefore apparent that an urgent need exists for further improved polymer films for packaging in the medical supply industry which are low cost, provide low failure rates, and provide low moisture transmission.